ICH Q11: what it is, who needs it, and how a drug substance process is assessed

What is ICH Q11?

ICH Q11 is the International Council for Harmonisation's guideline on the development and manufacture of a drug substance, chemical or biological, and on the information that goes into the drug substance sections of a marketing application. It is read with ICH Q7, the GMP guideline for the substance. A regulator assesses the application against it, and nobody certifies it.

It reached ICH Step 4 in May 2012, and the FDA and the EMA adopted it as guidance that November. A questions and answers document on the selection of starting materials followed in 2017. Its sections cover process development, the process description and its controls, starting material selection, the control strategy, process validation, its filing in Module 3.2.S of the CTD and lifecycle management.

Who needs ICH Q11?

Companies developing a new chemical or biological drug substance for a marketing application, since Q11 sets what the drug substance sections of the application have to say about the process, the starting materials and the control strategy

Drug substance manufacturers and the CDMOs who run the registered process, since an inspector compares the batch records with the process description and the control strategy the application filed

Companies changing an approved drug substance process, whether a step, a parameter or a starting material, since the control strategy on file decides what the change means and what has to be reported to the regulator

The guideline becomes urgent when the assessor's question list asks why the starting material was chosen where it was, when the CDMO proposes a route change to a step already filed, or when the pre-approval inspection compares the batch records with the process description in 3.2.S.2.2.

ICH Q11 IN QUALIO

Qualio maps your development and process records to Q11's sections, so the process the assessor read is the one the inspector finds

Qualio breaks Q11 down section by section, beside Q7 and Q10, and maps your process description, starting material justification and control strategy to the sections they answer, held with their approvals. When a record changes, it reassesses those sections and recommends a fix for any gap. Copilot drafts the change control for a process change, and your team approves it. When the inspector asks, you export the evidence by section.

The description of the manufacturing process and its controls held as a controlled document, each revision approved and signed, so the registered process and the one the batch records follow are the same version, for section 4

The starting material justification and the control strategy kept with their approvals and the development reports they rest on, so the answer to the assessor's question is the approved document, for sections 5 and 6

A change to a step, a parameter or a starting material raised as a change control with the linked procedures and specifications in view before anyone approves it, and the retraining out on the effective date, for lifecycle management under section 9

Q11 assessed beside ICH Q7, so the GMP records of the drug substance site and the development records behind the process are read against both guidelines on the same procedures

Standards that apply alongside ICH Q11

Pharma manufacturingICH Q7: GMP for active pharmaceutical ingredients, which applies from the starting material onward, so the step Q11 asks you to justify is the step where Q7 begins
Pharma manufacturingICH Q8: Pharmaceutical development for the drug product, whose concepts of a target product profile, critical quality attributes and a design space Q11 applies to the drug substance
Pharma manufacturingICH Q9: Quality risk management, the method Q11 expects behind the choice of critical quality attributes, the starting material justification and the control strategy
Pharma manufacturingICH Q10: The pharmaceutical quality system whose change management and knowledge management carry a Q11 control strategy through technology transfer and commercial manufacturing
Pharma manufacturingcGMP (21 CFR 210 and 211): The FDA's GMP regulation for the finished drug product made from the substance, with ICH Q7 as the FDA's GMP expectation for the substance itself

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Questions about ICH Q11

What is ICH Q11?

ICH Q11 is the International Council for Harmonisation's guideline on the development and manufacture of a drug substance, chemical or biological, and on how that work is described in a marketing application. It covers process development, the process description, starting material selection, the control strategy, process validation and lifecycle management. The FDA and the EMA adopted it as guidance.

What is the difference between ICH Q7 and ICH Q11?

Q7 is the GMP guideline for active pharmaceutical ingredients, the rules for how a drug substance is made, tested and released at the site. Q11 is about how the process was developed and justified, and what the application says about it. The two meet at the starting material, where Q11 asks you to justify the choice and Q7's GMP begins.

How is a starting material selected under ICH Q11?

Section 5 sets the principles. A starting material has a defined structure and properties. Changes early in the route have less effect on quality, so enough of the synthesis is described, and run under GMP, for the assessor to see how impurities form and are purged. The 2017 questions and answers added detail on justifying the choice.

Does ICH Q11 apply to biologics and to clinical-stage products?

It applies to chemical entities and to biotechnological and biological entities, with sections of its own on source materials and process validation for biologics. It is written for the marketing application and does not apply to clinical trial applications, though it says its development principles are worth applying during the investigational stages.

Can we add ICH Q11 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the records you already hold against every section, beside ICH Q7, Q8 and Q10 if you run those too. The process descriptions, specifications and change controls that answer Q7 count towards Q11 without being re-filed, and the first assessment lists what is covered and what is new.

Which starting material did the assessor question?

Bring the process description and the control strategy you filed. We will show you ICH Q11 assessed against them section by section, with the gaps listed and the evidence exported by section.

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